Efficacy and Tolerability Study of ZP-025 Vaginal Gel for the Treatment of Vaginal Dryness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-10-31

Brief Summary

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Evaluation of ZP-025 vaginal gel in terms of efficacy and safety in the treatment of vaginal dryness in post-menopausal women with vaginal atrophy in comparison to a group of non-treated post-menopausal women with vaginal atrophy after 56 consecutive days and at 4-week follow-up only for women applying ZP-025 vaginal gel.

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Detailed Description

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Evaluation of ZP-025 vaginal gel in terms of efficacy, tolerability and safety in the treatment of vaginal dryness in post-menopausal women with vaginal atrophy in comparison to a group of non-treated post-menopausal women with vaginal atrophy for 56 consecutive days.

This trial will be conducted in compliance with last version of Declaration of Helsinki, with GCP as applicable to investigations with IMD, with the applicable regulatory requirements and with CRO and Sponsor's SOPs.

This is a multi-centre, national, randomized, controlled vs. no-treatment, open label study The study will take place in 6 centers of menopause at public Hospitals/Universities. An ancillary study will be carried on for subjects randomized to ZP-025 group with a follow-up visit at 4 weeks

Conditions

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Vaginal Dryness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vaginal gel, Medical Device Class 2A

Every subject has been treated for 56 consecutive days, twice daily with a vaginal application

Group Type ACTIVE_COMPARATOR

Vaginal gel, Medical Device Class 2A

Intervention Type DEVICE

Application twice a day of vaginal gel for 56 consecutive days

Lifestyle counseling

Every subject has been observed for 56 consecutive days

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vaginal gel, Medical Device Class 2A

Application twice a day of vaginal gel for 56 consecutive days

Intervention Type DEVICE

Other Intervention Names

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Monurelle Biogel

Eligibility Criteria

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Inclusion Criteria

* caucasian women \<70 years, in physiological postmenopausal status for at least 2 years;
* women with signs and symptoms of vaginal atrophy (i. e. vaginal discomfort, itching, dyspareunia, dryness);
* signed informed consent; willing and able to comply with study procedures

Exclusion Criteria

* childbearing potential women;
* ascertained or presumptive hypersensitivity to the formulation ingredients;
* therapy with systemic or vaginal oestrogens within 6 months from the inclusion;
* current urinary or vaginal infection (cultural positive result to vaginal or urines microbiological swab in the 7 days preceding inclusion);
* previous episodes of vaginal bleeding or spotting in the last 6 months;
* vaginal prolapse and any other disease that could interfere with the study conduction and participation

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No